Presidential Commission for the Study of Bioethical Issues A FDA - - PowerPoint PPT Presentation

Presidential Commission for the Study

• f Bioethical Issues

A FDA Staff Perspective on Neurotechnology

Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Food and Drug Administration August 20, 2014

Tobacco Products

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Products that give off radiation Cosmeti etics Food Applications Veterinary Medicine Biologics Neurological Devices

Drug Delivery Systems

Dieta etary Supple plement nts

FDA’s Mission

Pharmace ceutica cals Medical Devices

In Vitro Diagnostics Neu Neuro- diagnos

• stics

cs

de deep br brain s stimul ulat ation exo xosk skeletons

Spinal Cord Stimulators

Wheelchairs

Brain Computer Interfaces

Walkers

Neuro rosurgical I l Instru ruments

Experience in Moving Neurological Medical Devices From Bench to Market

MERCI Retriever for Ischemic Stroke Cefaly Medical Device For Migraine DEKA Prosthetic Arm Microcatheters for the neurovasculature Epilepsy DBS ADHD Neurodiagnostics

Increasing Regulatory Transparency for Developers and Innovators

• Pre-Submission Guidance Document

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guid anceDocuments/UCM311176.pdf

• IDEs for Early Feasibility Clinical Studies Guidance

Document

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guid anceDocuments/UCM279103.pdf

• Guidance Documents

http://www.fda.gov/regulatoryinformation/guidances/

Division of Neurological and Physical Medicine Devices

Neurostimulation Devices

Deep Brain Stimulators Peripheral Nerve Stimulators Spinal Cord Stimulators Cranial Stimulators Vagus Nerve Stimulators

Neurodiagnostic & Neurosurgical Devices

Surgical Instruments Materials Diagnostic Devices Vascular Devices Therapeutic Devices

Physical Medicine & Neurotherapeutic Devices

Brain Computer Interfaces Functional Electrical Stimulators Exoskeletons Wheelchairs Walkers

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article that

Diagnoses, cures, mitigates, treats or prevents a disease or condition, or Affects the function or structure or the body, and Does not achieve intended use through chemical action I s not dependent upon being metabolized

What is a medical device?

Who makes medical devices?

• Generally: Any company or entrepreneurs who

produces a medical device for sale in the US » All manufactures must Register and List with the FDA http://www.fda.gov/MedicalDevices/DeviceRegulat ionandGuidance/HowtoMarketYourDevice/Registra tionandListing/ » Includes small businesses and entrepreneurs » Regulatory consultants

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A risk based approach for medical devices since 1976

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Class I

• General Controls

Class II

• General controls
• Special controls

Class III

• General controls
• Premarket approval (PMA)

Increasing Risk

Classification determines extent of regulatory control (Risk Based) General Controls

• Electronic Establishment Registration
• Electronic Device Listing
• Quality Systems
• Labeling
• Medical Device Reporting (MDR)
• Premarket Notification [510(k)] (unless exempt)

Special Controls (addressing Risk)

• Guidelines (e.g., Glove Manual)
• Mandatory Performance Standard
• Performance testing, such as biocompatibility,

engineering, animal, etc.

• Special Labeling

Direct to Consumer Devices

A Few Topics of Interest

(When does FDA Regulate)

Division Priorities

Transparency Predictability Efficiency Coordination Preparedness

Closing Thoughts

FDA Regulatory Review Resources

• FDA Home Page

http://www.fda.gov/

• CDRH Home Page

http://www.fda.gov/MedicalDevices/

• Division of Industry and Consumer Education (DICE) [Formerly

Division of Small Manufacturers, International, and Consumer Assistance (DSMICA)] - to ask general regulatory questions http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ ContactUs--DivisionofIndustryandConsumerEducation/default.htm

• Overview of Device Regulation

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview

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Thank You

• Dr. Carlos Peña

Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health carlos.pena@fda.hhs.gov